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French Trial Ended Due to Deaths Among Patients on Docetaxel-Doxorubicin Regimen
A breast cancer chemotherapy regimen that involved simultaneous administration of docetaxel and doxorubicin suppressed white blood cell activity in 40 percent of patients and led to two treatment-related deaths, concludes a report on the European RAPP-01 clinical trial published in the May 18 Journal of the American Medical Association.
The first death occurred in March 2000, when a 49-year-old patient became ill with abdominal pain 7 days after receiving the doxorubicin-plus-docetaxel regimen under study. She developed febrile neutropenia 2 days later and subsequently died. An autopsy was not performed, and the steering committee concluded that the death was "not specifically attributable" to docetaxel and decided to continue the trial. In January 2001, a second woman developed febrile neutropenia. She went into septic shock 6 days after her fourth cycle of doxorubicin and docetaxel but later recovered. In January 2003, a 39-year-old woman fell ill 6 days after first receiving the regimen. She died a week later from septic shock. The investigators ended the trial and switched the remaining patients in the docetaxel arm to the standard regimen of doxorubicin and cyclophosphamide.
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Advocates: Helping to Forge a Path to 2015
We use the term "cancer community" because, perhaps unlike any other disease area, there is a vast collection of groups and individuals who play an essential role in the cancer research enterprise. In my time as director of the National Cancer Institute (NCI), I've come to more fully appreciate the complexity, robustness, and diversity of this collective, especially with regard to the advocacy community and its remarkable success in advancing cancer research.
Just last week, for example, I participated in an event celebrating the 10th anniversary of the National Breast Cancer Coalition's Project LEAD. This program has helped to educate breast cancer advocates about the science of breast cancer, allowing them to work more closely with the research community in promoting new approaches to prevention, diagnosis, and treatment.
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The NCI Cancer Bulletin is produced by the National Cancer Institute (NCI). NCI, which was established in 1937, leads the national effort to eliminate the suffering and death due to cancer. Through basic, clinical, and population-based biomedical research and training, NCI conducts and supports research that will lead to a future in which we can identify the environmental and genetic causes of cancer, prevent cancer before it starts, identify cancers that do develop at the earliest stage, eliminate cancers through innovative treatment interventions, and biologically control those cancers that we cannot eliminate so they become manageable, chronic diseases.
For more information on cancer, call 1-800-4-CANCER or visit http://www.cancer.gov.
NCI Cancer Bulletin staff can be reached at ncicancerbulletin@mail.nih.gov.
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